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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044142
Receipt No. R000050405
Scientific Title A single-center prospective observational study to evaluate the usefulness of endoscopic diagnosis of superficial carcinoma of the head and neck using the GIF-1200N ultra-thin upper gastrointestinal endoscope and ENT endoscope
Date of disclosure of the study information 2021/06/01
Last modified on 2021/06/24

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Basic information
Public title A single-center prospective observational study to evaluate the usefulness of endoscopic diagnosis of superficial carcinoma of the head and neck using the GIF-1200N ultra-thin upper gastrointestinal endoscope and ENT endoscope
Acronym An observational study of superficial carcinoma of the head and neck using an ultra-thin endoscope
Scientific Title A single-center prospective observational study to evaluate the usefulness of endoscopic diagnosis of superficial carcinoma of the head and neck using the GIF-1200N ultra-thin upper gastrointestinal endoscope and ENT endoscope
Scientific Title:Acronym An observational study of superficial carcinoma of the head and neck using an ultra-thin endoscope
Region
Japan

Condition
Condition Superficial carcinoma of the Head and Neck
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of observation for superficial head and neck cancer using upper gastrointestinal endoscopy and otorhinolaryngological endoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visibility of abnormal vessels and demarcation line of the lesion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 ultra-thin upper gastrointestinal endoscope
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with superficial carcinoma of the head and neck who undergo oral surgery
Key exclusion criteria Patients determined to be ineligible
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Chikatoshi
Middle name
Last name Katada
Organization Kitasato University School of Medicine
Division name Gastroenterology
Zip code 252-0374
Address Kanagawa
TEL 0427788111
Email ckatada@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Koichi
Middle name
Last name Kano
Organization Kitasato University School of Medicine
Division name Otorhinolaryngology- Head and Neck Surgery
Zip code 252-0374
Address Kanagawa
TEL 0427788111
Homepage URL
Email kkent@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato university
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee, Kitasato University school of medicine - Hospital
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel 0427788111
Email rinrib@med.kitasato-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2021 Year 05 Month 07 Day
Date of IRB
2021 Year 05 Month 12 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 07 Day
Last modified on
2021 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050405

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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